6,6-dimethylcyclohex-2-en-1-one

Endpoint summary

Description of key information

The oral LD₅₀ of the test substance is 500 mg/kg bw in rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 February to 21 March 2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Study conducted in compliance with OECD Guideline 423 without any deviation but not under GLP.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test type:

acute toxic class method

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier, Le Genest-Saint-Isle, France
- Weight at study initiation: 192-235 g
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-23°C
- Humidity: 30-53 %

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg bw
300 mg/kg bw

No. of animals per sex per dose:

- Batch 1 (control): 6 rats females
- Batch 2 (2000 mg/kg): 3 rats females
- Batch 3 (300 mg/kg): 6 rats females

Control animals:

yes

Statistics:

None

Preliminary study:

Not Applicable

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

500 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at dose 300 mg/kg bw
Death was observed for the 3 rats treated at dose 2000 mg/kg bw

Clinical signs:

No clinical signs related to the administration of the test item were observed at dose 300 mg/kg bw.
A reduction in spontaneous activity, muscle tone and righting reflex were observed during the first hours of the treatment for the animals treated at 2000 mg/kg bw.

Body weight:

Body weight gain of the treated animals was not affected by test item at dose 300 mg/kg bw

Gross pathology:

At 2000 mg/kg bw, red coloration was observed in the fundic mucosa of the stomach. At 300 mg/kg bw, white thickening of the ventricular mucosa was observed in the stomach.

Other findings:

None

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for 6,6-DIMETHYL-2-CYCLOHEXENONE is 500 mg/kg bw in female rats therefore it is classified in category 4 (H302) according to CLP Regulation (EC) No 1272/2008.

Executive summary:

In an acute oral toxicity study performed according to OECD Guideline 423 (using acute toxic class method), Sprague Dawley female rats were treated with two doses, 2000 and 300 mg/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights and were all sacrificed for macroscopic examination.

No mortality was observed at dose 300 mg/kg bw and death was observed for the 3 rats treated at dose 2000 mg/kg.

No clinical signs related to the administration of the test item were observed at dose 300 mg/kg bw. Body weight gain of the treated animals was not affected by test item at dose 300 mg/kg bw.

Animals treated at 2000 mg/kg showed a reduction in spontaneous activity, muscle tone and righting reflex during the first hours of the treatment.

In this study, the oral LD50 of 6,6-DIMETHYL-2-CYCLOHEXENONE was considered to be 500 mg/kg bw in female rats.

Therefore, 6,6-DIMETHYL-2-CYCLOHEXENONE is lassified in category 4 (H302) according to CLP Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

500 mg/kg bw

Quality of whole database:

GLP study conducted according to OECD TG 423

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute oral toxicity study performed according to OECD Guideline 423 (using acute toxic class method), Sprague Dawley female rats were treated with two doses, 2000 and 300 mg/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights and were all sacrificed for macroscopic examination.

No mortality was observed at dose 300 mg/kg bw and death was observed for the 3 rats treated at dose 2000 mg/kg bw.

No clinical signs related to the administration of the test item were observed at dose 300 mg/kg. Body weight gain of the treated animals was not affected by test item at dose 300 mg/kg bw.

Animals treated at 2000 mg/kg bw showed a reduction in spontaneous activity, muscle tone and righting reflex during the first hours of the treatment.

Justification for classification or non-classification

The oral LD50 of the registered substance is 500 mg/kg bw in rats. Therefore it is classified in category 4 (H302) according to CLP Regulation (EC) No 1272/2008.